Bioequivalence Study of 8 mg Perindopril Tert-butylamine / 2.5 mg Indapamide Tablets Versus 10 mg Perindopril Arginine / 2.5 mg Indapamide Film-coated Tablets in Healthy Volunteers

Darnitsa Pharmaceutical Company42 enrolled

Overview

The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (PERINDOPRES® DUO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" \[Ukraine\]) and a Reference medication (marketed medicinal product Noliterax® 10 mg /2.5 mg, 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets \[manufactured by Servier (Ireland) Industries Ltd\]) in healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Bioequivalence Healthy Subjects

Interventions

Oral, generic fixed-dose combination of perindopril tert-butylamine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure) and indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure)

Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tabletsDRUG

Oral, innovative fixed-dose combination of perindopril arginine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure) and indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Healthy subjects, age 18 to 50 years, inclusive, body mass index (BMI) range is within 18.5 - 30.0 kg/m2, subject does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs, standard ECG assessment is normal (no QTc prolongation), medical history and physical examination within medically acceptable criteria, laboratory investigations tests within laboratory reference ranges (ALP and creatinine are accepted if below 5% of the reference range). Haematology tests within 5% of reference limits, the subject is willing to adhere to the protocol requirement throughout the study and to provide written informed consent.

Outcomes

Primary Outcomes

Maximum plasma concentration (Cmax) of perindopril

The Cmax values are based on perindopril plasma concentration.

Time frame: Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose

Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) of perindopril

The AUC0-t is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (t) and is based on perindopril plasma concentration.

Time frame: Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose

Cmax of indapamide

The Cmax values are based on indapamide plasma concentration.

Time frame: Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose

AUC0-t of indapamide

The AUC0-t is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (t) and is based on indapamide plasma concentration.